Associate Scientist, Biologics Characterization

Job Description

Join Takeda as a The Associate Scientist, Biologics Characterization plays a key role and will contribute to biologics characterization activities using mass spectrometry, biophysical methods, and/or HPLC/UPLC-based separations. You will independently plan, execute, analyze, and report characterization experiments to support product understanding, process development, comparability, stability, manufacturing readiness, technology transfer, and regulatory submissions. You will work with departmental and cross-functional partners to generate high-quality data, troubleshoot technical issues, and communicate results that support decision-making for biologics CMC.

You will bring hands‑on laboratory experience, technical curiosity, and the ability to develop expertise in one or more characterization platforms such as LC‑MS, peptide mapping, intact mass analysis, glycan analysis, UPLC/HPLC fractionation, AUC, CD, DSC, DLS, spectroscopy, or related protein characterization methods. This role does not include direct people management.

Associate Scientist, Biologics Characterization is responsible for managing and performing scientific research, development, and testing of new products, manufacturing processes, and raw materials. This role contributes to the development of innovative therapies by ensuring the quality and efficiency of manufacturing processes, supporting Takeda's mission to bring life-changing therapies to patients worldwide.

• Independently design, plan, execute, analyze, and report basic and complex biologics characterization experiments under general direction.
• Perform analytical and biophysical studies to assess biologics structure, heterogeneity, purity, stability, degradation pathways, post‑translational modifications, higher‑order structure, and product‑related variants.
• Apply methods such as LC‑MS, peptide mapping, intact mass, glycan analysis, HPLC/UPLC, electrophoretic methods, spectroscopy, thermal analysis, and other characterization tools.
• Contribute to characterization studies and source documentation supporting product and process understanding, comparability, stability, process or formulation development, technology transfer, and regulatory submissions.
• Prepare experimental protocols, technical reports, data summaries, method documents, technology transfer documents, and internal presentations.
• Interpret and communicate results to departmental colleagues, project teams, or cross‑functional partners with supervisor or project lead alignment.
• Serve as an Analytical Development characterization contact for assigned project activities and align with the supervisor or project lead before committing resources or timelines.
• Troubleshoot non‑routine method, sample, instrument, data analysis, software, documentation, or vendor‑related issues and propose solutions.
• Coordinate defined internal or external characterization activities, including review and consolidation of vendor data packages, as assigned.
• Propose and implement improved approaches for data collection, analysis, interpretation, visualization, and reporting within assigned scope.
• Stay current with relevant analytical technologies, biologics characterization methods, data analysis approaches, and regulatory expectations.
• Serve as a technical resource for selected laboratory technologies and may train or mentor colleagues, interns, and co‑ops.
• Present technical results internally and may contribute to posters, internal reports, external presentations, publications, invention disclosures, or patent‑related activities, as appropriate.
• Complete required training and maintain high standards for safety, data integrity, documentation quality, and laboratory compliance.

• Associate degree with 7+ years, bachelor’s degree with 5+ years, or master’s degree with 3+ years of relevant industry experience in analytical development, biologics characterization, protein chemistry, biochemistry, biophysics, analytical chemistry, or a related discipline.
• Previous hands‑on experience working in a laboratory setting is required.
• Experience with biologics characterization, protein…